GS1 RFIDを用いた手術機械の個体識別
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  • 1. Identification ofSurgical Instruments with RFID Kazuhiko YAMASHITA Tokyo Healthcare University Division of Healthcare Informatics k-yamashita@thcu.ac.jp
  • 2. TOKYO SKY TREEI wanna be a first climber! Spring ,2012 Can’t wait! Completion 634m
  • 3. Patient Safety & Quality Management - An urgent problem for Healthcare -Estimate of the death toll caused bymedical errors  98,000 / year in US by IOM report  23,000 / year In Japan by a report sponsored by MoH・Collection of accurate and quantitative data(data management)・Automated system for physicians, nurses,medical workers, and patients・Building Evidence for medical safety
  • 4. Problem of management on surgical instrumentsMedical errors at clinical sites Social problem Rate of incidents that surgical instruments or sponge are left inside human bodies : 1 / 10000 operation Frequency of errors in setting containers : 2% How frequently is the instrument used? Is quality assured? To whom is it used? Management of those items by RFID Computerized data management of surgical instruments (user friendly, burden free)
  • 5. Ceramic RFID tag for surgical instruments Carved seal ID ・Frequency 13.56MHz ・Diameter 6 mm, thickness 2mm①Applicable to metals,②Low dilatability → low troublerate,③Rigid →low damage
  • 6. Results of basic tests on RFID Tag1.sterilization test (cycle test)→50 tags30 min, pressure 1.5 kgf/cm2,50 cycles→trouble rate 0 %200 ℃, heating time 300 hours2. High temperature challenging test→20 tags→trouble rate: 0 %3. Water and ultrasonic test→80 tags28 kHz, 150 W, 30 min, 30 cycles→trouble rate: 0 %4. High pressure test → 10 tagsaverage pressure value 126.2kgf, 150 cycles→trouble rate: 0 %
  • 7. Durability & Contamination Tests at medical institute• Durability test by washer-disinfector →77 surgical instruments, 31 cycles• Durability test by autoclave →68 surgical instruments, 15 cycles• Contamination test by ATP method →35 surgical instruments(A pair of scissors, 7 Mosquito Clamps, 27 Kocher Clamps):After contaminated by sheep blood, cleaned by a washer-disinfector →Comparing Tag attachment section and Box- rock section
  • 8. Durability/Contamination TestsInstruments in a washing Setting in sterilizationbasket container Washer disinfector Autoclave
  • 9. Results of the tests• Durability test Malfunction, No communication : 0• Contamination Test →ATP Method:Luminescence test Tag attachment section:38.7±6.1 [RLU] Box-rock section:39.8±6.0 [RLU]Meet the standard of “less than100RLU” by Japanese Association for Operative MedicineNo breakage or separation of RFID tag
  • 10. Load Test of RFID Tag 1 0.8 加圧[kN] Load [kN] 0.6 0.4 0.2 0 1 137 273 409 545 681 817 計測点 Measurement point Test material : 6 surgical instruments Load : 0.9kN(9kgf), 10000 Cycles→breakage, drop out, no communication : 0
  • 11. Tag Reader/WriterThe movement of the instruments can bemonitored by Reader/Writer under spread No need of intentionalboard for surgical instruments. motion for reading
  • 12. Tag Reader/Writer
  • 13. Operation RoomThe reader/writer is equipped under the spread boardfor surgical instruments
  • 14. Data to be written in RFID• In accordance with Steel Instrument 2D Symbol Marking Guideline & GS1 Spec. (EPCglobal in the future)• Data Structure : to be based on ISO/IEC15418 GTIN-14 (AI) (AI) Serial No. (8 digit) 01 0 45 1234567 123 0 21 12345678Global standard a master data Common serial number of surgical instrument
  • 15. Actual use for human surgery
  • 16. Actual use for human surgery
  • 17. Summary• Developed RFID Tag for surgical instruments→Checked the basic performance of the tag attached to surgical instrument• Developed a reader/writer for operation room and central supply.• Developed a basis of software for collecting data
  • 18. Effects of surgical instrument with RFID Surgical instruments manufacturer Traceability, assist of individual management Central supply roomMaintenance, washing Setting containerand sterilization Increasing setBuild evidence on of container,surgical instruments For medical staff burden free and patient safetyChecking, number of Counting instrumentstimes, keeping quality before, during, afterof surgery, depreciation operationA system can check automatically, burden free on instruments count,management of asset in hospital increase quality of operation Operating room
  • 19. “Insanity:Continuing to do thesame thing and expectingdifferent results.” - Albert EinsteinContact us.Kazuhiko YAMASHITA:k-yamashita@thcu.ac.jp